Regulatory Affairs Manager

Summary

Regulatory Professional having diverse experience of managing and monitoring regulatory submissions and approvals in more than 22 countries.

Experiences

Current Experience

Manager Regulatory Affairs Since October 2014
- Responsible for Global Product Registration, Renewal Application & License Applications in All Countries.
- Responsible for Global Product Variation Applications in accordance with the requirement of Drug Regulatory Authority for any Product / System / Process related change.
- Monitor the Complete Registration Process of Submission and Approvals in all operating countries.
- Involve in Agreement Finalization with Regulatory and Trade Mark Consultants.
- Lead the Project for Feasibility of Products for Regulatory Submission and Marketing Authorization.
- Lead the Project for Launching & Commercialization of Consumer, Herbal & OTC Products.
- Responsible for Submission of NCE’s for EX-Registration Applications to DRAP.

Past Experience

Assistant Manager Regulatory Management January 2013 --- September 2014
- Responsible for final review of Product Registration, Renewal Application & License Applications.
- Responsible for final review of Product Variation Applications according to the requirements of respective Regulatory Authority for any Product / System / Process related change.
- Monitor registration processes and ensures timely submission and approvals in African Region (Kenya, Nigeria, Uganda, Sudan and Mauritius), Asian Countries (Pakistan, Yemen and Afghanistan), CIS Region (Kazakhstan & Tajikistan) and Francophone Countries (Ivory Coast & Cameroon).
- Review and verify all initial and developed product packaging artworks in accordance with country specific labeling requirements.
- Involve in finalization of Products for International Submission.
- Responsible for impact assessment of any variation received from various departments as per regulatory compliance.
- Review of change alerts for any change in regulatory system and ensures its implementation.
- Review and implement SOP’s within team.

Request Expert's contact details

Insert the role(s) you are contacting this Expert for.

Use max. 10 words to describe the role you are inviting this Expert for. (No costs attached, it is totally FREE)
Role = Jobtitle, expectations and competences you have from the Expert that receives this message. EXAMPLE: Senior CRA, USA, Hematology, Permanent Position, WeekendWork

Change Current Status

Current Status

Register and contact Experts for Free!

Get in contact with Life Science Experts without paying for your match!